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    The EU Clinical Trials Register currently displays   31553   clinical trials with a EudraCT protocol, of which   5083   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-006130-16
    Sponsor's Protocol Code Number:EFFECTS2012
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-06-16
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2011-006130-16
    A.3Full title of the trial
    ESTABLISHING THE EFFECT(S) AND SAFETY OF FLUOXETINE INITIATED IN THE ACUTE PHASE OF STROKE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ESTABLISHING THE EFFECT(S) AND SAFETY OF FLUOXETINE IN NON-DEPRESSED STROKE PATIENTS INITIATED IN THE ACUTE PHASE OF STROKE
    A.4.1Sponsor's protocol code numberEFFECTS2012
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKarolinska Institutet
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSwedish Stroke Association
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportThe Swedish Heart- Lungfund
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportKing Gustaf V and Queen Victoria Freemason Fund
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska Institutet
    B.5.2Functional name of contact pointKarolinska Institutet/Danderyds Hos
    B.5.3 Address:
    B.5.3.1Street AddressDanderyds Hospital
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code18288
    B.5.3.4CountrySweden
    B.5.4Telephone number46812357693
    B.5.5Fax number4687555951
    B.5.6E-mailveronica.murray@ki.se
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Oxactin
    D.2.1.1.2Name of the Marketing Authorisation holderNiche Generics Ltd,
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFluoxetine
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cerebrovascular diseases
    Både ischemisk och hemorrhagisk stroke
    E.1.1.1Medical condition in easily understood language
    Stroke
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Does the routine administration of Fluoxetine (20mg od) for 6 months after an acute stroke improve patients’ functional outcome?
    E.2.2Secondary objectives of the trial
    Does the routine administration of Fluoxetine (20mg od) for 6 months after an acute stroke:
    1. Improve patients’ motor function and does any improvement persist?
    2. Improve patients’ communication function and does any improvement persist?
    3. Improve patients’ outcome with respect to mood, fatigue, cognition, health related quality of
    life or participation in an active life and does any improvement persist?
    4. Reduce the cost of health and social care over the first year?
    5.Increase the risk of serious adverse events?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18
    2. Informed consent can only be obtained from a patient who according to the trial investigator is mentally capable of decision-making and who, after having received information and got answers to their questions, wants to participate in the trial
    3. Brain imaging is compatible with intra cerebral haemorrhage or ischaemic stroke
    4. Randomisation can be performed between 2 and 15 days after stroke onset and by the research group at the patient’s local/emergency hospital.
    5. Persisting focal neurological deficit is present at the time of randomisation severe enough to warrant treatment from the physicians and the patient’s and relative’s perspective.
    E.4Principal exclusion criteria
    1. Subarachnoid haemorrhage (except where secondary to a primary intracerebral haemorrhage).
    2. Unlikely to be available for follow up for the next 12 months e.g. no fixed home address.
    3. Unable to speak Swedish and no close family member available to help with follow up forms.
    4. Other life threatening illness (e.g. advanced cancer) that will make 12-month survival unlikely.
    5. History of epileptic seizures.
    6. History of allergy or contraindications to fluoxetine including:
    a) Hepatic impairment (S-ASAT/ALAT > 3 upper normal limit)
    b) Renal impairment (S-Creatinine levels > 180 micromol/L)
    7. Pregnant or breastfeeding, women of childbearing age not taking contraception. Minimum contraception is an oral contraceptive. An HCG-test is to be made prior randomisation and after the end of trial medication
    8. Previous drug overdose or attempted suicide.
    9. Already enrolled into a CTIMP.
    10. Current or recent (within the last month) depression requiring treatment with an SSRI antidepressant.
    11. Current use of medications which have serious interactions with fluoxetine
    a) Use of any mono-amino-oxidase inhibitor (MAOI) during the last 5 weeks
    Co-administration of Fluoxetine and a mono-amino-oxidase inhibitor (MAOI) may result in life threatening interactions. Therefore, patients on MAOI inhibitors are ineligible for the EFFECTS trial. Also, any patient in need of treatment with a MAOI must stop their trial treatment for at least 5 weeks before commencing the MAOI, or to be treated as in-patients by a psychiatrist.
    E.5 End points
    E.5.1Primary end point(s)
    Modified Rankin Scale, ordinal analysis
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    E.5.2Secondary end point(s)
    Survival at 6 & 12 months; Stroke Impact Scale; EQ5D-5L; MHI 5; Vitality subscale of the Heath Questionnaire, and cardio-vascular morbidity; DSM-diagnosis of depression; Adherence to medication; Adverse events; Resource use; and Investigations: NIHSS (motor function); one part of NGTA (comprehension, yes/no), MoCA (cognition), DSM-IV, and MADRS (if feasible) (mood), CGI frequency (emotionalism).
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 and 12 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned25
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1250
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1550
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1550
    F.4.2.2In the whole clinical trial 1550
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-30
    P. End of Trial
    P.End of Trial StatusOngoing
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